Protective effect of sublingual tablets of vitamin B12 and saffron against neurotoxicity of oxaliplatin in patients with colorectal and gastric cancer

Phase 3

Recruiting

Conditions: colorectal and gastric cancer.
Malignant neoplasm of ill-defined sites within the digestive system
C26.9

Registration Number: IRCT20200408046990N10

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Gastric or colorectal cancer for whom treatment with XELOX or mFOLFOX6 regimen will be started.
Age between 18 to 70 years

Exclusion Criteria

Liver failure (ALT and AST serum level more than two to three times the normal level at the beginning of treatment)
Renal failure (GFR<30 ml/min)
Having a history of allergy to saffron or cyanocobalamin
neuropathy history at the beginning of the study
Having diabetes mellitus, pernicious anemia, chronic giardiasis, or malabsorption syndrome
History of alcohol consumption, multivitamins containing B12, neuromodulator drugs such as anticonvulsants or calcium and magnesium
Smoking (more than ten cigarettes a day)
Patient dissatisfaction

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
europathy occurrence rate. Timepoint: at the beginning of each chemotherapy course. Method of measurement: based on NCI-CTC (national cancer institute-common toxicity criteria version3).;Sensory and motor electrophysiological examinations. Timepoint: At the beginning and at the end of study. Method of measurement: Electromyography.

Secondary Outcome Measures

Name	Time	Method
ALT serum level. Timepoint: at the beginning of the study, and 30, 60, 90 and 120 days after the beginning of the study. Method of measurement: Measurement of blood levels of ALT by the laboratory.;Serum creatinine levels. Timepoint: at the beginning of the study, and 30, 60, 90 and 120 days after the beginning of the study. Method of measurement: Serum creatinine level is measured by Jaffe method.;Serum of level AST. Timepoint: at the beginning of the study, and 30, 60, 90 and 120 days after the beginning of the study. Method of measurement: Measurement of blood levels of AST by the laboratory.